The global landscape on interchangeability of biosimilars

Abstract

Introduction: Biosimilars hold the potential to be an integral healthcare component that can significantly improve affordability and thereby accessibility of the otherwise expensive biotherapeutic products. Regulators, payors, and policymakers, each have a major role to play in successful adoption of biosimilars. One of the issues that has been a point of frequent discussion is that of interchangeability of biosimilars.

Areas covered: This article aims to review the position that the major regulatory bodies have taken on interchangeability of biosimilars. Key issues that remain are also discussed. Adalimumab and etanercept have been chosen as real-world case studies to demonstrate interchangeability considerations. The need for gaining global harmonization on interchangeability is highlighted.

Expert opinion: A global harmonization on the interchangeability can likely accelerate biosimilar adoption and result in better accessibility to biologics. Experience gained with real-world studies supports switching to biosimilars from originators however post-marketing pharmacovigilance should be in place to assess the risk-benefit profile of biosimilars in the long run.

Keywords: Adalimumab; biosimilar; etanercept; interchangeability; switching.